• 14 Danville Business Park, Kilkenny, R95 F727, Ireland
  • +353 56 779 0100
  • info@prochem.ie
  • GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland +353 21 206 6178 info@prochem.ie
  • Quality Assurance Specialist – Co. Carlow

    Role Summary:


    • A new opportunity has arisen for the role of a Quality Assurance Specialist at our client’s busy pharmaceutical site in Co. Carlow.
    • This is a 4-cycle shift pattern role.
    • Technical knowledge of sterile manufacturing processes required.
    • The successful candidate will perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk
    • Respond quickly to unplanned events, technical issues
    • Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance.


    Core Duties and Responsibilities


    • Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
    • Understanding of sterile manufacturing operations is preferred.
    • Ability to learn and utilize computerized systems for daily performance of tasks.
    • Ability to prioritize, manage multiple tasks, and meet deadlines.
    • Support the spot check/walk-through process of the production lines
    • Be involved in customer complaint investigation if required
    • Support the annual product quality reviews if required
    • Perform timely reviews on batch documentation (EBR’s) / line clearances/ assist in the resolution of concerns commensurate with the risk. Liaise with other Department representatives to promote improvements in GMP and Quality standards
    • Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities
    • Comply with the current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.
    • Foster a culture of continuous improvement by deploying site Six Sigma tools and support implementation of Model Area within operations from the start.
    • Fully understand relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements.


    Minimum Qualifications and Experience:


    • Degree qualification or equivalent (Science, Engineering, Technical)
    • Experience in Sterile Manufacturing
    • Sterile filling processes and equipment and support services experience
    • Lean Six Sigma Methodology experience desired
    • Have Operational experience of quality systems in a dynamic manufacturing environment e.g. SAP, Trackwise, MES
    • Good organizational skills and attention to detail
    • Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
    • Ability to learn and utilize computerized systems for daily performance of tasks.
    • Strong influencing skills
    • Demonstrable analytical and systematic problem-solving skills
    • Focus on Customers and Patients


    To Apply:


    If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:

    14 Danville Business Park, Kilkenny, Ireland
    +353 56 77 90100

    Click here to submit your CV

    Please note, we do not require agency assistance with this role.